NCT06856174

Brief Summary

Women living with HIV have been shown to experience more frequent and severe hot flashes and night sweats (collectively known as vasomotor symptoms) as compared to women living without HIV. This correlates with disturbed sleep, increased depressive symptoms, increased anxiety, worse mental function, interference with activities of daily living including work, and worse overall quality of life. Hormone therapy is considered to be the most effective therapy for hot flashes and night sweats and the most appropriate choice to prevent bone loss at the time of menopause for women without HIV. However, the usefulness of hormone therapy has not been specifically studied in women living with HIV. This trial is being done to see if:

  • There is evidence to support the use of hormone therapy (estradiol with or without progesterone) for the treatment of hot flashes and night sweats in women living with HIV
  • Hormone therapy improves mental function, mood, sleep, quality of life, bone health, heart health, and inflammation in women living with HIV
  • Hormone therapy is safe and tolerable for women living with HIV

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for phase_4

Timeline
14mo left

Started Apr 2026

Geographic Reach
1 country

23 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Apr 2026Sep 2027

First Submitted

Initial submission to the registry

February 19, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 9, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

February 19, 2025

Last Update Submit

May 20, 2026

Conditions

MenopauseHIV Infection

Outcome Measures

Primary Outcomes (1)

  • Change in vasomotor symptoms (VMS) frequency

    Change in self-reported mean VMS frequency per day from 5-week observation phase prior to randomization to the one-week period prior to week 12 visit following.

    From 5 weeks prior to randomization to Week 12

Secondary Outcomes (16)

  • Change in vasomotor symptom (VMS) severity

    From 5 weeks prior to randomization to week 12

  • Change in sleep

    From randomization to week 12

  • Change in insomnia

    From randomization to week 12

  • Change in quality of life

    From randomization to week 12

  • Percentage of participants with adverse events associated with hormone therapy

    From randomization to week 12

  • +11 more secondary outcomes

Study Arms (2)

Arm A: Hormone Therapy

ACTIVE COMPARATOR

PARTICIPANTS WITH INTACT UTERUS: Transdermal estradiol gel plus oral micronized progesterone daily for 12 weeks. PARTICIPANTS WITHOUT A UTERUS: Transdermal estradiol gel daily for 12 weeks.

Drug: Transdermal estradiol gelDrug: Micronized Progesterone

Arm B: Hormone Therapy Placebo

PLACEBO COMPARATOR

PARTICIPANTS WITH INTACT UTERUS: Transdermal placebo gel plus oral encapsulated placebo pill daily for 12 weeks. PARTICIPANTS WITHOUT A UTERUS: Transdermal placebo gel alone daily for 12 weeks.

Drug: Placebo for estradiol gelDrug: Placebo for micronized progesterone

Interventions

Placebo for micronized progesteroneDRUG

• Participants with intact uterus: Encapsulated placebo for micronized progesterone 100 mg orally once daily for 12 weeks.

Arm B: Hormone Therapy Placebo
Transdermal estradiol gelDRUG

All participants: Estradiol gel 0.1%, 0.75 grams (corresponding to estradiol 0.75 mg) applied to the skin of the upper thigh once daily for 12 weeks.

Arm A: Hormone Therapy
Micronized ProgesteroneDRUG

Participants with intact uterus: Encapsulated micronized progesterone 100 mg orally once daily for 12 weeks.

Arm A: Hormone Therapy
Placebo for estradiol gelDRUG

All participants: Placebo for estradiol gel 0.1%, 0.75 grams applied to the skin of the upper thigh once daily for 12 weeks.

Arm B: Hormone Therapy Placebo

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
* Living with HIV * Assigned female sex at birth * Between the ages of 40 and 60 years * In the late menopausal transition (perimenopause) or early postmenopause * Experiencing hot flashes and/or night sweats * Willing and able to complete a daily diary * Does not have medical condition that would contraindicate hormone therapy * Not taking medications to treat hot flashes * Not taking medications that cannot be combined with hormone therapy * Receiving antiretrovirals (HIV medication) for more than 1 year * Not pregnant and willing and able to use at least non-hormonal birth control to prevent pregnancy * Willing and able to provide informed consent after discussion with the research staff

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (23)

31788 Alabama CRS

Birmingham, Alabama, 35294, United States

RECRUITING

University of California, Los Angeles CARE Center CRS (601)

Los Angeles, California, 90035, United States

RECRUITING

UCSD Antiviral Research Center CRS (701)

San Diego, California, 92103, United States

RECRUITING

801 University of California, San Francisco HIV/AIDS CRS

San Francisco, California, 94110, United States

RECRUITING

Harbor - UCLA Med. Ctr. CRS

Torrance, California, 90502, United States

RECRUITING

University of Colorado Hospital CRS (6101)

Aurora, Colorado, 80045, United States

RECRUITING

The Ponce de Leon Center CRS (5802)

Atlanta, Georgia, 30308, United States

RECRUITING

Northwestern University CRS (2701)

Chicago, Illinois, 60611, United States

RECRUITING

201 Johns Hopkins University CRS

Baltimore, Maryland, 21205, United States

RECRUITING

101 Massachusetts General Hospital (MGH) CRS

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham and Women's Hosp. ACTG CRS (107)

Boston, Massachusetts, 02115, United States

RECRUITING

2101 Washington University Therapeutics (WT) CRS

St Louis, Missouri, 63110, United States

RECRUITING

New Jersey Medical School Clinical Research Center CRS (31786)

Newark, New Jersey, 07103, United States

RECRUITING

Weill Cornell Chelsea CRS (7804)

New York, New York, 10010, United States

RECRUITING

Columbia Physicians and Surgeons (P&S) CRS (30329)

New York, New York, 10032, United States

RECRUITING

3201 Chapel Hill CRS

Chapel Hill, North Carolina, 27516, United States

RECRUITING

3203 Greensboro CRS

Greensboro, North Carolina, 27401, United States

RECRUITING

2401 Cincinnati CRS

Cincinnati, Ohio, 45267-0405, United States

RECRUITING

Case CRS (2501)

Cleveland, Ohio, 44106, United States

RECRUITING

Ohio State University CRS (2301)

Columbus, Ohio, 43210, United States

RECRUITING

6201 Penn Therapeutics CRS

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Univ of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Houston AIDS Research Team CRS (31473)

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Central Study Contacts

ACTG ClinicalTrials.gov Coordinator

CONTACT

301-628-3348ACTGCT.gov@dlhcorp.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2025

First Posted

March 4, 2025

Study Start

April 9, 2026

Primary Completion (Estimated)

September 20, 2027

Study Completion (Estimated)

September 20, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie results in the publication, after deidentification.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 3 months following publication and available throughout period of funding of the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) by NIH.
Access Criteria
* With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG). * For what types of analyses? To achieve aims in the proposal approved by the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG). * By what mechanism will data be made available? Researchers may submit a request for access to data using the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections Group (ACTG) "Data Request" form at: https://actgnetwork.org/about-actg/templates-and-forms. Researchers of approved proposals will need to sign an Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) Data Use Agreement before receiving the data.

Locations

US(23)